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Cartiva® implant details: The background and development of a harmful medical procedure
The FDA approved the Cartiva® Synthetic Cartilage Implant (SCI) in July 2016 for treating mid-stage to advanced arthritis at the base of the great toe.
In 2018, Wright Medical paid an estimated $435 million to acquire Cartiva®.
The Cartiva® implant is made from saline solution and polyvinyl alcohol–the same material as in soft contact lenses–and is almost the same size and shape of a mini-marshmallow.
The company has touted a variety of benefits that include:
- The reduction of joint pain without sacrificing the foot's natural range of motion;
- The retention of the patient's mobility and movement; also,
- Patients may return to daily activities faster than patients who undergo a traditional fusion procedure, because of a less restrictive rehabilitation protocol.
Composed of a biocompatible, durable, low-friction organic polymer, the Cartiva® implant is designed to function similarly to natural cartilage as it compresses and expands much like real cartilage–and it can be implanted in about 35 minutes.
Cartiva® implant dangers: What makes this dangerous medical device an injury waiting to happen
Known as the MOTION trial, Cartiva®'s pivotal trial showed significantly higher pain scores, including a case series with mixed results and numerous online complaints from dissatisfied implant patients.
The following elements make the Cartiva® medical implant a potential danger to patients:
- Smooth implant surface. Because the Cartiva® implant is very smooth on all surfaces, it creates a functional flaw in the design that may lead to serious injuries post-operation.
- Subchondral plate violation. Without subchondral plate support–and with no alternative means of support–the Cartiva® implant situates into the soft metaphyseal bone, making it prone to impaction failure.
- Little to no osseointegration. Osseointegration, or ingrowth of bone into the implant, is described as an essential aspect of implant stability–the absence of which is detrimental to surgical success
- Placement in soft bone offers little support. Implant of Cartiva® into the supporting bone means the structure is too weak to provide the meaningful, long-term support required to resist the load applied to the implant.
“While some of the patients are satisfied with Cartiva®, a majority are dissatisfied with many citing pain that lasts longer than they expected," reveals Mike Matson, a medtech analyst at Needham & Co.
The Shield Justice Watch team believes that patients that received a Cartiva® implant and then suffered a serious medical injury diagnosis should be able to seek justice and compensation from the manufacturer in a court of law.
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